MOBIS II 5° B25180929

GUDID 04047844015797

The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is avaible in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

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Primary Device ID04047844015797
NIH Device Record Key7c8403d5-2690-4f8c-993b-7790c57a4f7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOBIS II 5°
Version Model NumberLumbar cage, angled
Catalog NumberB25180929
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844015797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-10-11
Device Publish Date2015-09-24

On-Brand Devices [MOBIS II 5°]

04047844016176The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016169The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016152The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016145The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016138The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016121The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016114The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016107The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016091The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016084The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016077The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016060The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016053The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015902The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015889The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015872The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015865The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015858The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015841The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015834The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015827The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015810The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015803The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015667The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015896The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015797The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
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